Objectives:This study examined the utility of a novel
technique for reuse of thrombosed veins when extracting permanent
pacemaker leads via a femoral vein approach.Background: Although lead extraction permanent
pacemaker using a femoral approach has advantages over the subclavian
approach, it cannot be used to provide access for a new lead using
currently employed techniques. This is important because up to 23% of
patients have occluded veins after permanent pacemaker implantation. Methods: The pacemaker lead to be extracted was
released from the generator and retaining sutures at the implantation
site. The lead was then grabbed from below using a needle-eye-snare or
basket. The lead was then cut short and a drag through technique
performed where a guide
wire was pushed into the gap between the insulation and the coil. This
guide wire was then drawn into the right atrium as the lead was pulled
down from below. This guide wire was then used to introduce a sheath
through which a replacement lead could be inserted.Results: A total of 34 consecutive patients (21 male,
aged 63±14 years, mean±SD) had 57 (1.7/patient) leads
extracted. Fourteen patients required implantation of a new system and
were suitable for immediate lead replacement using the drag through
technique. All
leads were successfully extracted, with 5 partial successes (9.1% of
leads). The drag-through technique was successful in all, including 4
with subclavian vein occlusion. Procedure and fluoroscopy times,
including
the time required for implantation of a new system, were 143±65
mins and 31±23 mins respectively. There were no complications
and hospital stay was 1.6±1.2 days for patients undergoing the
drag-through procedure.Conclusion: The drag-through technique can be
successfully used to provide access in order to replace pacemaker leads
removed using a femoral approach.

Key Words: pacemaker, lead extraction,
femoral, drag-through

Condensed Abstract: Thirty-four patients had 57 leads
extracted using a femoral approach. In those patients requiring
immediate replacement of a pacing lead access for a new lead was
achieved in all cases by loosely attaching a guide wire and dragging it
into the right atrium behind the explanted lead. A sheath was then
introduced over the guide wire and the new lead introduced.

Introduction

Permanent pacemaker lead extraction using a minimally invasive
percutaneous approach has been made possible with the development of
specialised equipment and techniques1.
Further developments such a laser assisted lead extraction have
facilitated this2,3 but
despite these developments the major complication rate of these
procedures stands at approximately 1-3%2,4. One of the important reasons for this is that
the fragile subclavian vein, superior vena cava and right atrium may
tear during the process of cutting away the fibrous tissue that
enfolding the leads in these regions. Drawing the body of the lead,
which has the narrowest profile (cf. the tip and electrodes), through
this fibrous sleeve from below using a femoral approach, avoids the
need for this dissection and should prevent these important
complications. A
further advantage of the femoral approach is that the dissection down
to
the subclavian vein, required when using a superior approach, can be
painful
and time consuming. This is not required when using a femoral approach
and
therefore the procedure can be performed under local anaesthetic. The
major
disadvantage of the femoral lead extraction approach is that it does
not
provide access for a replacement lead which can be a problem in the
large
number of patients with permanent pacemakers who have subclavian vein
occlusion5. This study investigated the
feasibility of a modification to the conventional femoral lead
extraction technique that provides venous access allowing the
introduction of a new pacing lead along the channel
occupied by the extracted lead.

Methods

Patients: All
patients requiring lead extraction were included in this study.
Patients were
considered unsuitable for the reintroduction of pacing leads if there
was evidence of infection, if they had a functioning system in addition
to failed leads or the pacemaker lead had failed because of crushing
between
the first rib and the clavicle. Otherwise introduction of a new lead
using
the extracted lead channel was attempted in all patients.

Lead Extraction Procedure: The patients were taken
to the cardiac catheter laboratory in a fasted state having signed
informed consent. A temporary pacing wire was positioned at the right
ventricular apex, under local anaesthetic, via the left femoral vein.
Sedation and analgesia were given in the form of midazolam and
diamorphine at the patient's request. The pacemaker implantation site
was infused with 1% lignocaine local anaesthetic and opened along the
previous insertion scar. The generator was then removed from its pocket
and the lead/s requiring extraction were cut near the generator. The
lead was freed to the point where it was fixed by retaining
sleeves/sutures and these sutures were removed. A 16 French sheath was
inserted under local anaesthetic in the right femoral vein and either a
basket and deflecting wire (Byrd femoral workstation) or a
needle-eye-snare were introduced and the lead snared.
The drag-through technique was then performed in the following way. The
pacing lead was cut short with a one inch of lead left exposed. The
outermost electrode coils of the pacemaker lead were then grabbed with
an artery clip and stretched out from the lead insulation (figure 1).
While tension was applied to the coil it was then cut at the outer
insulation, resulting in the coil inside the lead being partially
unwrapped, leaving a gap between the outer insulation and the coil. A
140cm 0.35" J-tipped guide wire was then introduced into the gap left
between the coil and
the insulation and pushed in until it was firmly attached (figure 2).
No other method was used to affix the guide wire and specifically no
sutures or ties were used to fix the two together. The proximal end of
the pacemaker lead was then pulled down into the right atrium from
below while the guide wire was gently fed in, as it was drawn in behind
the pacing lead. When the proximal pacing lead/guide wire join reached
the level of the right atrium the guide wire was fixed and the pacing
lead pulled so that the
two separated (figure 3).
The pacemaker lead was then extracted using previously described
conventional counter-traction techniques6.
The guide wire was then used to introduce a "peel-away" sheath through
which a new pacing lead was then passed.

Figure 1: The generator has been removed and the lead to be extracted
cut short. Retaining sutures and sleeves have been taken off the lead
to
be extracted. The coil has been grasped with artery clips and pulled
out
from the insulation. The coil is then cut at the point where it extends
from the insulation (inset), which leaves a gap between coil and
insulation.
Note that a functioning atrial lead has been left undisturbed (with a
stillette inserted).

Figure 2: A guide wire is pushed into the gap between the coil and the
insulation so that it becomes fairly firmly attached to the lead.

Figure 3: The guide wire has been pulled in behind the lead and has
been detached at the level of the right atrium. Note that the atrial
lead
has been left undisturbed and can be used for the new pacing system.
Inset: the guide wire is used to pass a "peel-away" sheath to allow
introduction of a new pacing lead.

Definitions: Outcomes of the lead extraction were
based on previously published recommendations.7
Complete success was defined as removal of all material from the
vascular space. Partial success was defined as removal of all but a
small portion of the lead. Clinical success was defined as achievement
of all clinical goals
associated with the indication for lead removal.

Statistics

Continuous data is presented as means and standard deviations

Results

Patients
A
total of 34 consecutive patients (21 male, aged 63±14 years,
mean±SD) underwent extraction of 57 leads which had been in situ
for 7.8±4.4 years (7±3.3 years for drag-through
patients). Seventeen patients had infected systems and were therefore
not suitable for immediate replacement (table 1). Of the
remaining patients, one required radiotherapy for breast carcinoma on
the ipsilateral side, and another had a long section an active fixation
lead floating free in the right atrium following a
failed attempt to extract it from the superior approach at another
centre.
Therefore, 15 patients were suitable for lead extraction and immediate
replacement of their pacing system, 2 of whom required extraction of an
old pacing system in order to implant a defibrillator. The indications
for lead extraction in the remaining patients were lead failure in a
young
patient (<60 years) (n=7), Telectronics accufix lead removal was
requested
by two patients. One patient requested lead removal for pain and
discomfort,
whilst in another X-ray identified the cause of lead failure as a crush
fracture between the clavicle and first rib such that new leads were
implanted
via the cephalic vein to prevent this occurring again.

Procedure
Leads were extracted using a Byrd femoral workstation in 16 patients
(Cook UK Ltd) and a needle eye snare in 17 patients (Cook UK Ltd) and
both in 1 patient (Table 1).
Clinical success was achieved in all
cases. Radiographic success was achieved in 100% of leads with 91.2%
(52/57leads) complete
success; partial success resulting from retention of either the
electrode
(n=3) or <2cm of the distal end of the lead (n=2). The drag though
technique was attempted in 93% (14/15) of patients suitable for
immediate replacement of a pacing system on the ipsilateral side. Four
of these patients (31%) had total subclavian vein occlusions identified
on venography prior to
extraction. Achieving venous access via the drag-through technique was
successful in all patients and was used to extract and replace 19
pacemaker
leads. Four lead extraction procedures were performed under general
anaesthetic
(11.7% of subjects). The indications for general anaesthetic were
concurrent
defibrillator (ICD) implantation (n=2), septicaemic shock resulting in
confusion (n=1) and a heavily infected wound requiring extensive
debridement
(n=1). Two patients undergoing a drag-through procedure had 3 leads
removed
including 2 previously abandoned ventricular leads. Eight patients had
one lead extracted only (5 ventricular, 2 ICD, 1 atrial) with a
functioning
pre-existing lead left undisturbed in 3 cases (all atrial). A single
guide
wire was dragged-through and used to introduce 2 sheaths allowing
upgrade
from a single chamber to a dual chamber pacemaker in 1 patient,
otherwise
individual guide wires were introduced for each lead being replaced.
Mean
procedure and fluoroscopy times for all femoral lead extractions,
including the time required for implantation of a new system, were
143±65 minutes
and 31±23 minutes. For the patients undergoing a pacemaker lead
drag-through
and re-implantation procedure the times were 156±71 minutes and
41±28 minutes compared with 134±62 minutes and
25±18
minutes for those not undergoing drag through (p=NS). Mean stay in
hospital
was 4.5±6.7 days for all patients(presumably should quote
non-drag
sub-group rather than total group) and 1.5±1.1 days for the
drag-through
patients, reflecting the lack of infection in these patients.

Table
1

* indicates patients with venous
occlusion of the ipsilateral veins. Indication:
Pain=painful pacemaker; Failure=lead failure and the
patient
is young ( > 60)); Advisory=an
advisory lead and the patient has requested lead extraction; ICD=patient
required upgrading of pacemaker to ICD or replacement of a failed
defibrillator lead. System: the system in situ requiring
extraction; DDD=dual chamber; VVI and AAI=single
chamber. Extracted: the number of each type of leads extracted.
Tech: the system used to perform lead extraction; S=needle
eye snare; B=Byrd femoral workstation. Anaesth: LA=local;
GA=general anaesthetic. Rem: indicates whether any
lead fragments were retained; N=none; distal=<2cm
of distal lead was retained. Drag: how many leads were replaced
by the drag through technique; */*=number of leads dragged
through/number of requiring extraction. Proc and Fluoro:
procedure and
fluoroscopy time (mins) including time for new implants.

Discussion

Permanent pacemaker lead extraction has published major
complication and mortality rates of 1.4% and 0.04%4
and the results are similar using laser assisted lead extraction with
major complication and mortality rates of 3.2% and 0.6%2.
Perforation of the superior vena cava (SVC) or the lateral right atrium
contributes to complications observed during extraction from a superior
approach. Extracting pacemaker leads from a femoral approach should
avoid
these problems because there is no dissection performed in the right
atrium
or superior vena cava. Most published series of femoral lead extraction
have described cases that have already had an attempt at extraction
from
a superior approach, but a recently published series in which femoral
lead
extraction was the primary approach in most patients have reported no
major
complications or deaths in 78 patients, supporting the theoretical
safety
of this approach3.
The limitation of femoral lead extraction is that there is no access
for replacement of a new pacing system. This is of particular relevance
in those patients with subclavian or brachiocephalic vein occlusions,
which occurs in up to 23% of patients with permanent pacemakers9.Lead extraction and replacement of the lead on
the same side avoids the possibility of bilateral subclavian
occlusions,
failure to cross a superior vena or the need to implant a femoral
system.
Recent reports have demonstrated that replacing pacemaker leads through
occluded veins is possible particularly when using a laser-assisted
approach10. This study has demonstrated
that replacement
of permanent pacing leads is possible using the cheaper femoral
approach
even when the veins are occluded. This was achieved without
complication
and was performed under local anaesthetic in most cases. Obliteration
or
occlusion of all useable veins is currently a class I indication for
lead
extraction as recommended by the North American Society for Pacing and
Electrophysiology (NASPE)7 but occlusion of
the ipsilateral subclavian vein is not included as an indication. If,
as
limited data published so far has suggested, the femoral approach is
safer
than a superior approach, the indications for lead extraction could be
extended to include ipsilateral subclavian venous occlusion as a class
2 indication based on the technique described in this study.

Conclusion

Replacement of non-functioning pacemaker leads using the same route of
access as the extracted lead can be safely achieved using a femoral
approach. In the majority of cases the femoral lead extraction can be
used as the approach of choice. Occlusion of the subclavian vein is a
new indication for lead extraction using a femoral approach.